Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Double-blind, randomized, placebo-controlled study to explore the efficacy and safety of elobixibat compared to placebo in adults with NAFLD (nonalcoholic fatty liver disease) or NASH (nonalcoholic steatohepatitis)
A total of 15 investigators at 15 sites received institutional review board (IRB)/ethics committee (EC) approval to participate in this study and enrolled at least 1 participant.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Elobixibat | Experimental | Elobixibat 5 mg once daily |
|
| Placebo | Placebo Comparator | Placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Elobixibat | Drug | Elobixibat is a small molecule and a potent inhibitor of the ileal bile acid transporter (iBAT). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Serum Low Density Lipoprotein-cholesterol (LDL-C) at Week 16 | The primary efficacy endpoint was the change from Baseline in serum LDL-C at Week 16. Baseline was defined as the last non-missing LDL-C value prior to the first dose of study drug. | Week 16 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | An adverse event (AE) was any untoward medical occurrence in enrolled participant regardless of causal relationship with study drug. An SAE was defined as any AE that, at any dose, resulted in death, was life-threatening, resulted in persistent or significant disability/incapacity, required or prolonged hospitalization, was a congenital anomaly/birth defect or an important medical event. TEAEs were defined as AEs that were new or worsened after the first dose of study drug. |
Not provided
Key Inclusion Criteria:
Key Exclusion Criteria:
Body mass index (BMI) <25 kg/m2
Fibrosis-4 index (Fib-4) >2.6
Any of the following laboratory abnormalities:
Uncontrolled Type 2 diabetes defined as hemoglobin A1c (HbA1c) >9.5%
Clinical hyperthyroidism or hypothyroidism or screening hormone results pointing to thyroid dysfunction.
Uncontrolled hypertension
Participants with known intolerance to MRI or with conditions contraindicated for MRI procedures
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hope Clinical Research | Canoga Park | California | 91303 | United States | ||
| Inland Empire Clinical Trials, LLC |
The study consisted of a 6-week screening period followed by a 16-week treatment period and a follow-up visit 2 weeks after the last dose of study drug.
This double-blind, randomized, placebo-controlled, phase 2 study was conducted at 15 sites in the United States to explore the efficacy and safety of elobixibat (oral dose of 5 milligrams [mg]) once daily for 16 weeks in participants with nonalcoholic fatty liver disease (NAFLD) or nonalcoholic steatohepatitis (NASH).
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Elobixibat | Elobixibat 5 mg once daily Elobixibat: Elobixibat is a small molecule and a potent inhibitor of the ileal bile acid transporter (iBAT). |
| FG001 | Placebo | Placebo Placebo oral tablet: Placebo identical in appearance to active drug |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Elobixibat | Elobixibat 5 mg once daily Elobixibat: Elobixibat is a small molecule and a potent inhibitor of the ileal bile acid transporter (iBAT). |
| BG001 | Placebo | Placebo Placebo oral tablet: Placebo identical in appearance to active drug |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Serum Low Density Lipoprotein-cholesterol (LDL-C) at Week 16 | The primary efficacy endpoint was the change from Baseline in serum LDL-C at Week 16. Baseline was defined as the last non-missing LDL-C value prior to the first dose of study drug. | The intent-to-treat (ITT) population included all randomized participants who received at least 1 dose of study drug. | Posted | Least Squares Mean | Standard Error | "mmol/L" | Week 16 |
|
Adverse events and deaths were collected from first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months
Analysis was performed on the safety analysis set.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Elobixibat | Elobixibat 5 mg once daily Elobixibat: Elobixibat is a small molecule and a potent inhibitor of the ileal bile acid transporter (iBAT). |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Patrick Horn, MD, PhD | Albireo AB | +1 (857) 378- 2035 | medinfo@albireopharma.com |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Sep 10, 2019 | Aug 4, 2021 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jul 6, 2020 | Aug 4, 2021 | SAP_001.pdf |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D065626 | Non-alcoholic Fatty Liver Disease |
| ID | Term |
|---|---|
| D005234 | Fatty Liver |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C581303 | elobixibat |
Not provided
Not provided
Not provided
Double-Blind, Randomized, Placebo-Controlled
Not provided
Not provided
Not provided
| Placebo oral tablet | Drug | Placebo identical in appearance to active drug |
|
|
| From first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months |
| Absolute Change From Baseline to Week 16 in Liver Fat Fraction | The effect of elobixibat on liver steatosis was measured by magnetic resonance imaging (MRI) for liver fat fraction using proton density fat fraction [PDFF]). Baseline was defined as the last non-missing value prior to the first dose of study drug. | Baseline (Day 1) and Week 16 |
| Absolute Change From Baseline to Week 16 in Total Liver Fat | The effect of elobixibat on liver steatosis was measured by MRI for total liver fat using whole liver fat volume. Baseline was defined as the last non-missing value prior to the first dose of study drug. | Baseline (Day 1) and Week 16 |
| Change From Baseline to Week 16 in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma-glutamyl Transferase (GGT) | Serum samples were collected at specified timepoints to assess ALT, AST and GGT levels. Baseline was defined as the last non-missing value prior to the first dose of study drug. | Baseline (Day 1) and Week 16 |
| Change From Baseline to Week 16 in High-density Lipoprotein (HDL) Cholesterol, Non-high-density Lipoprotein Cholesterol and Triglycerides | Blood samples were collected at specified timepoints to assess HDL and non-HDL cholesterol levels and triglycerides. Baseline was defined as the last non-missing value prior to the first dose of study drug. | Baseline (Day 1) and Week 16 |
| Change From Baseline to Week 16 in Low-density Lipoprotein (LDL) Cholesterol to High-density Lipoprotein Cholesterol Ratio | Blood samples were collected at specified timepoints to assess LDL and HDL cholesterol levels and ratio was obtained. Baseline was defined as the last non-missing value prior to the first dose of study drug. | Baseline (Day 1) and Week 16 |
| Change From Baseline to Week 16 in Total Bile Acids | Blood samples were collected at specified timepoints to assess total bile acid levels. Baseline was defined as the last non-missing value prior to the first dose of study drug. | Baseline (Day 1) and Week 16 |
| Rialto |
| California |
| 92377 |
| United States |
| Peak Gastroenterology Associates | Colorado Springs | Colorado | 80907 | United States |
| Integrity Clinical Research, LLC | Doral | Florida | 33166 | United States |
| Nature Coast Clinical Research | Inverness | Florida | 34452 | United States |
| Guardian Angel Research Center, Inc. | Tampa | Florida | 33614 | United States |
| Mercy Medical Center | Baltimore | Maryland | 21202 | United States |
| American Research Corporation at the Texas Liver Institute | San Antonio | Texas | 78215 | United States |
| Virginia Commonwealth University | Richmond | Virginia | 23298 | United States |
| University of Washington | Seattle | Washington | 98195 | United States |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Disease under study | One participant was counted under both NAFLD and NASH per case report form (CRF) collected data. | Count of Participants | Participants |
|
| Duration of disease (Years) | One participant was counted under both NAFLD and NASH per case report form (CRF) collected data. | Mean | Standard Deviation | years |
|
Placebo
Placebo oral tablet: Placebo identical in appearance to active drug
|
|
|
| Secondary | Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) | An adverse event (AE) was any untoward medical occurrence in enrolled participant regardless of causal relationship with study drug. An SAE was defined as any AE that, at any dose, resulted in death, was life-threatening, resulted in persistent or significant disability/incapacity, required or prolonged hospitalization, was a congenital anomaly/birth defect or an important medical event. TEAEs were defined as AEs that were new or worsened after the first dose of study drug. | The safety population included all participants who were randomized and received at least 1 dose of study drug. | Posted | Count of Participants | Participants | No | From first dose of study drug (Day 1) up to end of follow-up per participant, approximately 13 months |
|
|
|
| Secondary | Absolute Change From Baseline to Week 16 in Liver Fat Fraction | The effect of elobixibat on liver steatosis was measured by magnetic resonance imaging (MRI) for liver fat fraction using proton density fat fraction [PDFF]). Baseline was defined as the last non-missing value prior to the first dose of study drug. | The ITT population included all randomized participants who received at least 1 dose of study drug. Only those participants with data collected at Baseline and Week 16 are reported. | Posted | Least Squares Mean | Standard Error | percent of liver fat | Baseline (Day 1) and Week 16 |
|
|
|
| Secondary | Absolute Change From Baseline to Week 16 in Total Liver Fat | The effect of elobixibat on liver steatosis was measured by MRI for total liver fat using whole liver fat volume. Baseline was defined as the last non-missing value prior to the first dose of study drug. | The ITT population included all randomized participants who received at least 1 dose of study drug. Only those participants with data collected at Baseline and Week 16 are reported. | Posted | Least Squares Mean | Standard Error | milliliter | Baseline (Day 1) and Week 16 |
|
|
|
| Secondary | Change From Baseline to Week 16 in Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST) and Gamma-glutamyl Transferase (GGT) | Serum samples were collected at specified timepoints to assess ALT, AST and GGT levels. Baseline was defined as the last non-missing value prior to the first dose of study drug. | The ITT population included all randomized participants who received at least 1 dose of study drug. Only those participants with data collected at Baseline and Week 16 are reported. | Posted | Least Squares Mean | Standard Error | Units/liter | Baseline (Day 1) and Week 16 |
|
|
|
| Secondary | Change From Baseline to Week 16 in High-density Lipoprotein (HDL) Cholesterol, Non-high-density Lipoprotein Cholesterol and Triglycerides | Blood samples were collected at specified timepoints to assess HDL and non-HDL cholesterol levels and triglycerides. Baseline was defined as the last non-missing value prior to the first dose of study drug. | The ITT population included all randomized participants who received at least 1 dose of study drug. Only those participants with data collected at Baseline and Week 16 are reported. | Posted | Least Squares Mean | Standard Error | millimoles/liter | Baseline (Day 1) and Week 16 |
|
|
|
| Secondary | Change From Baseline to Week 16 in Low-density Lipoprotein (LDL) Cholesterol to High-density Lipoprotein Cholesterol Ratio | Blood samples were collected at specified timepoints to assess LDL and HDL cholesterol levels and ratio was obtained. Baseline was defined as the last non-missing value prior to the first dose of study drug. | The ITT population included all randomized participants who received at least 1 dose of study drug. Only those participants with data collected at Baseline and Week 16 are reported. | Posted | Least Squares Mean | Standard Error | ratio | Baseline (Day 1) and Week 16 |
|
|
|
| Secondary | Change From Baseline to Week 16 in Total Bile Acids | Blood samples were collected at specified timepoints to assess total bile acid levels. Baseline was defined as the last non-missing value prior to the first dose of study drug. | The ITT population included all randomized participants who received at least 1 dose of study drug. Only those participants with data collected at Baseline and Week 16 are reported. | Posted | Least Squares Mean | Standard Error | micromoles/liter | Baseline (Day 1) and Week 16 |
|
|
|
| 0 |
| 23 |
| 0 |
| 23 |
| 13 |
| 23 |
| EG001 | Placebo | Placebo Placebo oral tablet: Placebo identical in appearance to active drug | 0 | 24 | 0 | 24 | 10 | 24 |
| Nausea | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Abdominal pain | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Bacterial abdominal infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
|
| Hordeolum | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
|
| Tooth infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
|
| Diarrhoea infectious | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
|
| Ear infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
|
| Urinary tract infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
|
| Vaginal infection | Infections and infestations | MedDRA 22.0 | Non-systematic Assessment |
|
| Dizziness | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Paraesthesia | Nervous system disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Type 2 diabetes mellitus | Metabolism and nutrition disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA 22.0 | Non-systematic Assessment |
|
| Blood triglycerides increased | Investigations | MedDRA 22.0 | Non-systematic Assessment |
|
| Hypertension | Vascular disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Neck pain | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Non-cardiac chest pain | General disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Renal pain | Renal and urinary disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Prostatomegaly | Reproductive system and breast disorders | MedDRA 22.0 | Non-systematic Assessment |
|
| Hyperhidrosis | Skin and subcutaneous tissue disorders | MedDRA 22.0 | Non-systematic Assessment |
|
Albireo will retain the ownership of all data. All proposed publications based on this study must be subject to the sponsor's approval requirements.
| Unknown or Not Reported |
|
| Black or African American |
|
| Native Hawaiian or Other Pacific Islander |
|
| White |
|
| Other |
|
| GGT |
|
| Triglycerides |
|